FDA cleared the Alexis lighted wound protector-retractor, flexible, extra small (cl312);Alexis lighted wound protector-retractor, flexible, small (cl301);Alexis lighted wound protector-retractor, flexible, medium (cl302);Alexis lighted wound protector-retractor, flexible, large (cl303);Alexis lighted wound protector-retractor, rigid, small (cl401);Alexis lighted wound protector-retractor, rigid, medium (cl402); Alexis lighted wound protector-retractor, rigid, large (cl403) from Applied Medical Resources Corporation on Apr 24, 2026 under K260982, a special 510(k). The device falls under product code KGW, Ring (Wound Protector), Drape Retention, Internal, regulated at 21 CFR 878.4370 as a Class 2 device. The review panel was General, Plastic Surgery.
FDA logged the submission as received on Mar 25, 2026. The decision came 30 days later, inside the 90 FDA-day goal for a 510(k).
Applied Medical Resources Corporation has 5 other decisions in the tracker over the last 12 months: K253531 (Alexis® Lighted Wound Protector-Retractor, Rigid, Medium (CL402); Alexis® Lighted Wound Protector-Retractor, Flexible, Medium (CL302)), K252740 (Voyant® Open Fusion Device (EB240/Open Fusion)), K252412 (Voyant® Electrosurgical Generator (EA030/Electrosurgical Generator)), K252442 (Kii Structural Balloon Access System).
Questions & Answers
What did FDA clear under K260982?
K260982 is the FDA 510(k) for Alexis lighted wound protector-retractor, flexible, extra small (cl312);Alexis lighted wound protector-retractor, flexible, small (cl301);Alexis lighted wound protector-retractor, flexible, medium (cl302);Alexis lighted wound protector-retractor, flexible, large (cl303);Alexis lighted wound protector-retractor, rigid, small (cl401);Alexis lighted wound protector-retractor, rigid, medium (cl402); Alexis lighted wound protector-retractor, rigid, large (cl403), submitted by Applied Medical Resources Corporation. FDA's decision date was Apr 24, 2026, under product code KGW (Ring (Wound Protector), Drape Retention, Internal).
Who makes the Alexis lighted wound protector-retractor, flexible, extra small (cl312);Alexis lighted wound protector-retractor, flexible, small (cl301);Alexis lighted wound protector-retractor, flexible, medium (cl302);Alexis lighted wound protector-retractor, flexible, large (cl303);Alexis lighted wound protector-retractor, rigid, small (cl401);Alexis lighted wound protector-retractor, rigid, medium (cl402); Alexis lighted wound protector-retractor, rigid, large (cl403)?
Applied Medical Resources Corporation, based in Rancho Santa, CA, is the applicant of record for K260982.
How long did the K260982 review take?
FDA received the submission on Mar 25, 2026 and issued its decision on Apr 24, 2026, 30 days later.